
Pie Medical
Free shipping on orders over $99 · 30-day returns
MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K053154) manufactured by Pie Medical. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 15, 2005. Regulation: 8.